Bradycardia, Heart Failure
Conditions
Brief summary
The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in the setting of a post-market clinical follow-up study.
Interventions
DEVICEAmvia/Solvia pacemaker family
Implantation of a pacemaker or CRT-P devices
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Standard indication for de novo, upgrade or replacement pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation * Ability to understand the nature of the study * Willingness to provide written informed consent * Ability and willingness to perform all follow-up visits at the study site * Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring® concept
Exclusion criteria
* Planned for conduction system pacing * Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months * Known pregnancy or breast feeding * Age less than 18 years * Participation in another interventional clinical investigation * Life-expectancy less than 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SADE-free rate at 6 months | 6 months | Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRT AutoAdapt performance | 12 months | CRT AutoAdapt: different pacing percentages |
| CRT AutoAdapt AV delay | 12 months | Mean adapted AV delay after pace/sense |
| Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator | 12 months | Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor) |
| Auto LV VectorOpt | 12 months | Time needed for threshold measurement |
| SADE-free rate at 12 months | 12 months | Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months |
| aATP-related ADEs and SADEs | 12 months | aATP-related ADEs and SADEs |
| Sensing performance of device-based measurements | 12 months | The appropriateness of sensing performance will be assessed by calculating the percentage of appropriate sensing for all leads. |
| Pacing performance of device-based measurements | 12 months | The appropriateness of pacing performance will be assessed by calculating the percentage of appropriate pacing for all leads. |
| Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator | 2 months | Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor) |
Countries
Austria, Germany
Outcome results
None listed